5 Deaths Linked To Obesity Stomach Balloons, FDA Warns quoting : law360

5 Deaths Linked To Obesity Stomach Balloons, FDA WarnsLaw360, New York (August 10, 2017, 3:43 PM EDT) -- The U.S. Food and Drug Administration informed health providers Thursday that five patients with fluid-filled balloons used to treat obesity have unexpectedly died since last year. Four patients with Apollo Endosurgery Inc.'s Orbera Intragastric Balloon System and one patient with ReShape Medical Inc.'s ReShape Integrated Dual Balloon System died within a month of the systems' insertions, the FDA said. The report follows a February warning that the balloons, designed to combat obesity by taking up stomach space, could overinflate or contribute to acute pancreatitis. "The FDA...To view the full article, register now.




Aug. 10, 2017 -- Five people who had a balloon system put into their stomach to treat obesity have died since 2016, the FDA warned Thursday. Four of the reports to the FDA involve the Orbera Intragastric Balloon System (Apollo Endosurgery), and one report involves the ReShape Integrated Dual Balloon System (ReShape Medical), the FDA said in a safety alert. All five patients died within a month or less of balloon placement. Three patients died 1 to 3 days afterward. The FDA has also received two other reports of deaths since 2016 related to potential balloon treatment problems: one case where a person got stomach hole, with the Orbera Intragastric Balloon System, and one who got an esophagus hole, with the ReShape Integrated Dual Balloon System.

FDA: Deaths Following Intragastric Balloon Placement for Obesity

FDA: Deaths Following Intragastric Balloon Placement for ObesityOrbera Intragastric Balloon System manufactured by Apollo EndosurgeryThe Food and Drug Administration (FDA) has issued a warning regarding reports of deaths that occurred in patients with liquid-filled intragastric balloon systems used to treat obesity since 2016. Four patients had the Orbera Intragastric Balloon System (by Apollo Endosurgery) placement and one patient had the ReShape Integrated Dual Balloon System (by ReShape Medical, Inc.) placement. Deaths in all five patients occurred within one month of balloon placement with three occurring as early as 1–3 days after placement. The FDA has also received two additional reports of death within the same time period that may possibly be related to balloon placement: one gastric perforation associated with Orbera Intragastric Balloon System and one esophageal perforation associated with ReShape Integrated Dual Balloon System. In February 2017, clinicians were asked to closely monitor patients with liquid-filled intragastric balloon systems used to treat obesity for risks of acute pancreatitis and spontaneous over-inflation.


collected by :Lucy William

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